Clinical Trials in Relapsing-Remitting Multiple Sclerosis /A New Proposal for Dealing with Basic Problems and Restrictions/

摘要

The natural course of multiple sclerosis is characterized by a high variability of pattern, relapse rate and different progression indices. They also present a dramatic impact on the interpretation of treatment trials. Reports, based on uncontrolled observations are therefore of little value. Currently it is generally accepted that a proper treatment trial should be double blinded and, although probably controversial, that it should be compared with a group of MS patients treated with placebo.Currently MS is considered as a generalized degenerative disease. The lesions are persistent, which is the reason why im-munomodulatory treatment has to be started as early as possible. An alternative approach, somewhat suggestive for the use of placebo trials, seems to be a comparison of proposed new drug therapy group with a group of patients treated with a generally accepted reference drug.